TB5 Ref Test/Blank Sensor 673396000

GUDID 00630414132013

Reference Test/Blank sensor, an in vitro diagnostics device to replace the Reference sensor on the RAPIDLab® 248/348/348ex analyzers

Siemens Healthcare Diagnostics Inc.

Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care

• Primary Device ID: 00630414132013
• NIH Device Record Key: 05379764-c8b7-4127-bd5f-276818d70020
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TB5 Ref Test/Blank Sensor
• Version Model Number: 10327492
• Catalog Number: 673396000
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414132013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934907

FDA Product Code

• CHL: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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